Device Recall SpineWave

  • Model / Serial
    Lot Codes: 092514Z, 120814A, 011415H and 022415F
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    US Nationwide Distribution in the state of CA, FL, GA, LA, MA, MD, MI, MO, NC, NH, OH, OR, PA, TX, and VA.
  • Product Description
    Spine Wave Access Kit, Catalog Number 10-1530 || Package contents: RLSP494-Rhythmlink Monopolar Stimulating Probe and 10-1525 Disposable Dilator Set. || Product Usage: || The Spine Wave Access Kit is comprised of a sterile monopolar stimulating probe (individually packaged by Rhythmlink International) and a set of three sterile disposable dilators (individually packaged by Spine Wave). The Rhythmlink International Monopolar Stimulating Instrument is indicated for stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
  • Manufacturer
  • 1 Event


  • Manufacturer Address
    Spine Wave, Inc., 3 Enterprise Dr Ste 302, Shelton CT 06484-4694
  • Manufacturer Parent Company (2017)
  • Source